NCT06715059

Brief Summary

The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis. Researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with DRA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

November 21, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

inter-recti distancepostural controlpelvic floor dysfunctionbody-self relationabdominal endurance

Outcome Measures

Primary Outcomes (2)

  • Inter-recti distance

    The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus

    baseline

  • Inter-recti distance

    The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus

    after 8 weeks

Secondary Outcomes (6)

  • Abdominal muscle endurance test

    baseline

  • Abdominal muscle endurance test

    After 8 weeks

  • Pelvic floor dysfunction

    baseline

  • Pelvic floor dysfunction

    After 8 weeks

  • Body-self relation

    baseline

  • +1 more secondary outcomes

Study Arms (2)

Tele-rehab group

EXPERIMENTAL

The participants who performed exercise program via online platform.

Other: Tele-rehabilitation exercise program

Home-based group

EXPERIMENTAL

The participants who performed exercise program in the home.

Other: Home-based exercise program

Interventions

A progressive core stability exercise program will be performed based on motor control principles via an online platform.

Tele-rehab group

A core stability exercise program will be performed at home.

Home-based group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post- partum women (min 1 - max 5 years)

You may not qualify if:

  • Having a neurological, orthopedical or any other condition which affect postural stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Atlas University

Istanbul, KAgıthane, Turkey (Türkiye)

Location

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Study Officials

  • Hilal DENİZOĞLU KÜLLİ

    İSTANBUL ATLAS ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 4, 2024

Study Start

November 2, 2021

Primary Completion

December 20, 2022

Study Completion

November 20, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations